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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / June 2026 / K254034

510(k) cleared

Roosin Collagen Powder

Roosin Medical Co., Ltd. · Jun 3, 2026 · K254034

FDA cleared the Roosin Collagen Powder from Roosin Medical Co., Ltd. on Jun 3, 2026 under K254034, a traditional 510(k). The device falls under product code KGN, Wound Dressing With Animal-Derived Material(S) as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Dec 16, 2025. The decision came 169 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Roosin Medical Co., Ltd. has one other decision in the tracker over the last 12 months: K253974 (Roosin Collagen Dressing).

Questions & Answers

What did FDA clear under K254034?

K254034 is the FDA 510(k) for Roosin Collagen Powder, submitted by Roosin Medical Co., Ltd.. FDA's decision date was Jun 3, 2026, under product code KGN (Wound Dressing With Animal-Derived Material(S)).

Who makes the Roosin Collagen Powder?

Roosin Medical Co., Ltd., based in Taizhou, is the applicant of record for K254034.

How long did the K254034 review take?

FDA received the submission on Dec 16, 2025 and issued its decision on Jun 3, 2026, 169 days later.

← All decisions in June 2026

Sources